Breath of fresh air

Sandpoint manufacturer cleared to sell ventilators

With help from a local inventor’s video and the work of Idaho’s District 1 congressman, the Food and Drug Administration has given a pioneering North Idaho ventilator manufacturer clearance to introduce compact ventilator systems into a market in dire need of them.

Percussionaire’s TXP5 had been waiting for approval for quite some time, but it’s not the only ventilator in the company’s arsenal.

The Sandpoint company has spent more than a month ramping up production on its ventilators as the coronavirus continues to wreak respiratory and cardiopulmonary havoc on the world. The pandemic has infected about 850,000 — including 37 in the Idaho Panhandle — and killed more than 41,000 worldwide. The crisis is what prompted Brent Regan, a Coeur d’Alene inventor who works in partnership with Percussionaire, to spread the word that a reliable weapon in the war against COVID-19 is close by.

“I do not want to see people die,” Regan said of ventilator-induced lung injury, also known as VILI.

VILI is not so much the result of the coronavirus but actually more the result of carelessness, Regan said. It’s been a concern of his since a surge of individuals began creating do-it-yourself ventilators out of everything from sleep apnea CPAP machines to snorkeling masks, releasing their designs through open-source sharing.

It’s a movement that gives Regan pause.

“These DIY open source ventilators are frightening,” Regan told The Press. “Lungs are not elastic like balloons. They are more like paper bags. Once they are fully inflated, if you continue to force in air they will rupture. Not good.”

The TXP5 is not new ventilator technology as much as it’s new in design, Regan said in the video, adding that the easier-to-use system will reserve traditional heavy-duty ventilators for the most ill and in-need patients.

The four components of the new ventilator delivery system — a pressure regulator, a pneumatic oscillator, a meter and a Percussionaire Phasitron, all FDA-approved and already part of health care providers’ arsenals — was the sticking point.

“The problem is that this particular configuration is not FDA-approved, even though all the pieces, all the technology, is in medically-approved ventilators right now,” Regan said in the four-minute video. “So we don’t have a technology problem. We’ve got a government regulation problem.”

Regan contacted Congressman Russ Fulcher to help get Percussionaire’s device in front of the right eyes for approval.

“Brent reached out to me and said, ‘These guys are not being utilized,’” Fulcher told The Press on Tuesday. “Brent’s got a great idea for a low-cost, high-production device. Through my office, we put the wheels in motion to put the right people with Percussionaire. But true to government form, nothing really happened.”

Fulcher said he spent the past few days on the phone, pushing for the ventilator to get the support it needs to enter the marketplace.

“Since last Friday I’ve been on the phone, just dialing for contacts because the traditional channels are not functional,” he said.

It started with the Centers for Disease Control, then went to Health and Human Services, then to the Federal Emergency Management Agency.

Fulcher said the struggle was particularly frustrating after the federal government recently voiced encouragement over a joint venture by Ford and General Electric to dedicate some of their manufacturing resources to ventilator production.

“GE and Ford were doing a joint venture to make 50,000 [ventilators] in 100 days,” Fulcher said. “Percussionaire can do that now — and they don’t have to start from scratch.”

Fulcher said Percussionaire — founded by the late Dr. Forrest Bird, inventor of one of the first mass-produced mechanical ventilators and credited with helping carry the world out of the era of the iron lung — has been ramping up production on its ventilators as the pandemic continues to spread.

An estimate of what the unit would retail for was not available Tuesday.

Regan said he’s received positive feedback from his and Fulcher’s push to get Percussionaire’s approval problem resolved.

“Social distancing flattens the curve so that more people are covered under the line of maximum health care capacity,” Regan said. “The other thing we can do is raise the line, increasing the number of people that can be treated. My goal is to be sure that everyone who needs a ventilator has access to one.”

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See Brent Regan video:

bit.ly/2w3jpdz